Institutional Review Board, Hospital for Special Surgery
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
The purpose of the Scleroderma Registry is to gather as much information as we can about as many patients as possible who have this rare condition. This will facilitate investigators in developing a better understanding of its clinical features, pathobiology (the study of the biological changes in the body caused by disease), and genetic links. With this increased knowledge, investigators hope to identify the unmet needs of patients with scleroderma and develop new and better treatments to improve disease outcomes and quality of life. Patients will be asked to allow researchers to gather information about their background and medical history, obtain and store their blood, serum, plasma, and tissue samples and gather clinical information on them. Approximately 300 patients will be enrolled during the course of this registry. Patients will be followed-up with every four (+/-1) months.
Anyone diagnosed with scleroderma will be included in this registry, while those who do not have scleroderma will not.